CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are:

(1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Other: Diabetes Treatment; Other: Usual Care Group

Detailed Description

Data from continuous glucose monitoring (CGM) in the Glucose Lowering group tracked over time, will be compared to data from blinded sensors in the Usual Care group approximately every 4 weeks.

• Pregnant women who do not have diabetes and have a single, uncomplicated pregnancy will be enrolled by 14 weeks and 6 days. They will start by wearing a hidden CGM sensor to check for high blood sugar.

• The blinded CGM sensor data will be evaluated to determine if the following criterion is met: 5% to <25% of values >140 mg/dL

  • An initial assessment will be made after 5 days and for those not meeting the criterion, again after 10 days

• Participants meeting the CGM hyperglycemia criteria and the other study eligibility criteria will proceed to randomization, which must be performed by 16 weeks 6 days of gestation.
• Participants who do not meet the CGM hyperglycemia criteria will form an observational cohort, provided that HbA1c is <6.5% (48 mmol/mol)

• Study Type: Interventional
• Enrollment (Estimated): 6000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judy Sibayan, MPH, CCRP, Epidemiologist; Phone Number: 813-975-8690; Email: jsibayan@jaeb.org
• Study Contact Backup: Name: Paige N Miller, BS; Phone Number: 813-975-8690; Email: pmiller@jaeb.org

Study Locations

• United Kingdom
  • Leeds
    • Leeds, Leeds, United Kingdom
      • Not yet recruiting
      • Leeds Teaching Hospitals NHS Trust
      • Contact: Eleanor Scott; Phone Number: +44 7876 031952; Email: E.M.Scott@leeds.ac.uk
      • Principal Investigator: Eleanor Scott
  • Norwich
    • Norwich, Norwich, United Kingdom
      • Not yet recruiting
      • Norfolk and Norwich University Hospitals NHS
      • Contact: Helen Murphy; Phone Number: +44 1603 286286; Email: Helen.Murphy@uea.ac.uk
      • Principal Investigator: Helen Murphy
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35173
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Jennifer Bryant; Phone Number: 832-453-8402; Email: jlbryant@uabmc.edu
      • Principal Investigator: Ashley Battarbee
  • Florida
    • Miami, Florida, United States, 33016
      • Recruiting
      • University of Miami
      • Contact: Stephanie Cardona; Phone Number: 305-585-5610; Email: stephanie.cardona@miami.edu
      • Principal Investigator: Alfredo Rodriguez
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Recruiting
      • Emory University
      • Contact: Olivia Carter; Email: olivia.carter2@emory.edu
      • Principal Investigator: Suchitra Chandrasekaran
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Recruiting
      • IDC at Park Nicollet
      • Principal Investigator: Anders Carlson
      • Contact: Shannon Krizka; Phone Number: (952) 993-3393; Email: shannon.krizka@parknicollet.com
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • ICAHN School of Medicine at Mount Sinai
      • Contact: Shaziah Hassan; Phone Number: 212-241-5355; Email: Shaziah.hassan@mssm.edu
      • Principal Investigator: Carol Levy
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Stacey Ehrenberg; Phone Number: 216-618-7235; Email: ehrenbs@ccf.org
      • Principal Investigator: Stacey Ehrenberg
      • Principal Investigator: Cara Dolin
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Monica Rincon; Phone Number: 503-494-8748; Email: rincon@ohsu.edu
      • Principal Investigator: Amy Valent
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Elizabeth Norton; Phone Number: 973-600-8830; Email: elizabeth.norton@pennmedicine.upenn.edu
      • Principal Investigator: Celeste Durnwald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Maternal age of 18 years and older
2. Singleton pregnancy

3. Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening

   • Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available

4. HbA1c <6.5% (48 mmol/mol) since onset of pregnancy

   • If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility.

5. No prior history of gestational diabetes mellitus (GDM)
6. Able to read English or Spanish

Exclusion Criteria

1. Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
2. Planned termination of pregnancy or any indications of miscarriage
3. Prior gastric bypass surgery
4. Pregravid diabetes (type 1 or type 2)
5. Unwillingness/inability to wear CGM sensor
6. Unwillingness to attend routine antenatal obstetric appointments

7. Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening

   • Topical and inhaled corticosteroids are acceptable

8. Use of insulin during the pregnancy prior to enrollment
9. Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening
10. Deemed unable to participate for medical reasons identified by their physician

Additional Criteria for RCT Eligibility

1. Screening CGM meeting study criteria for hyperglycemia: 5% to <25% time >140 mg/dL
2. Randomization by 16 week 6 days of pregnancy
3. No participation in a separate intervention trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observational
Experimental: Glucose Lowering Group	Other: Diabetes Treatment; Management will include an unblinded CGM sensor worn 24/7, GDM specific nutrition information, training on using CGM in daily glucose management to achieve euglycemia (maximizing time 63-140 mg/dL [3.5-7.8 mmol/L]). Visits (which could be telehealth) per usual obstetrical care for glycemia management (expected to be about every 4 weeks for most participants) and weekly glycemic management with review of CGM data by site and by central CGM Resource Center for flagged cases. Participants not receiving glucose lowering medication by 24-28 weeks will undergo OGTT per usual obstetrical management and those with positive OGTT will be treated for GDM per usual clinic routine and continue to wear an unblinded CGM.; Other Names: Continuous Glucose Monitoring
Active Comparator: Usual Care Group (with periodic blinded CGM)	Other: Usual Care Group; The control group will receive usual obstetrical care at the clinical center. A general pregnancy nutrition information handout will be provided to each participant and a blinded CGM sensor will be placed at routine obstetrical care visits and worn for 10-14 days each time throughout the pregnancy beginning between 18-22 weeks' gestation. At 18-22 weeks, blinded CGM data will be reviewed to assess if participant has ≥25% time >140 mg/dL to determine if an early OGTT or glycemic management is required. Site clinicians will be unblinded to the masked CGM data for participants with CGM data ≥25% time >140 mg/dL and those participants may be treated as those with a positive OGTT. An OGTT will be performed at ~24-28 weeks per the clinic's usual routine and those with positive OGTT will be treated for GDM per usual clinic routine. If real-time CGM is to be used, then unblinded study CGM sensors can be used instead of blinded sensors for the duration of the study.; Other Names: Blinded Continuous Glucose Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy	Composite endpoint of (1) neonatal complications of large for gestational age (LGA), shoulder dystocia (including humeral or clavicular fracture), elevated bilirubin requiring phototherapy, or neonatal intensive care unit (NICU) admission; or (2) maternal hypertensive disorder of pregnancy (HDP) .	Baseline to 45 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Neonatal Complications, Death, and Maternal Complications	Composite of neonatal complications; Individual maternal and neonatal complications; Neonatal death	Baseline to 45 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Small for Gestational Age Birth Weight	Small for gestational age birth weight (<10th percentile)	Baseline to 45 weeks
CGM-Measured Time Less Than 54 mg/dL	CGM-measured time less than 54 mg/dL (during comparative periods where Usual Care group has blinded CGM)	Through study completion, an average of 30 months
Severe Hypoglycemia Events	Severe Hypoglycemia Events	Through study completion, an average of 30 months

Collaborators and Investigators

• Sponsor: Jaeb Center for Health Research
• Collaborators: Abbott; DexCom, Inc.; The Leona M. and Harry B. Helmsley Charitable Trust
• Investigators: Study Chair: Celeste Durnwald, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2025
• Primary Completion (Estimated): November 27, 2027
• Study Completion (Estimated): November 27, 2027

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; CGM; GDM
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes, Gestational; Hyperglycemia; Pregnancy in Diabetics; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: IMAGINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No